NCT04068818已完成不适用
The Heidelberg Engineering ANTERION Imaging Agreement Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 87
- 试验地点
- 1
- 主要终点
- Image quality
研究概览
简要总结
This is a prospective clinical study that will be conducted at one clinical site located in the United States to assess image quality of acquired biometry images of the eye
详细描述
The conducted study is a non-interventional study for an imaging device used in the aid of ophthalmology diagnosis. Because the study is not interventional, the study is not an Applicable Clinical Trial per Clinicaltrials.gov definition.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 22 years or older
- •Able and willing to undergo the test procedures, sign informed consent, and follow instructions
- •Able to fixate
- •With eye pathology status for each of the two eye populations. A. Eye with normal anterior segment
- •B. Eyes with anterior segment abnormalities identified with the slit lamp exam including but not limited to:
- •glaucoma surgeries: trabeculectomy, laser peripheral iridotomy and drainage devices
- •corneal surgeries: corneal inlays and corneal transplants
- •pterygium and corneal scar
排除标准
- •Subjects which were enrolled in the B-2018-1 Study
- •Physical inability to be properly positioned at the study devices or eye exam equipment
- •Contact lenses worn during imaging
结局指标
主要结局
Image quality
时间窗: 30 days
Comparison of the B-Scan image quality between the ANTERION and the reference device
Agreement in identification of abnormality
时间窗: 30 days
Agreement in identification of abnormality from OCT B-Scan images between ANTERION and the reference device
次要结局
- Adverse Events(1 day)
研究者
研究点 (1)
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